Monteleukast Versus Inhaled Mometasone for Treatment of Otitis Media With Effusion in Children

Hormozgan University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Otitis Media With Effiusion

Treatments: Drug: Monteleukast; Drug: Mometasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02541760

163

Details and patient eligibility

About

Otitis media is one of the most common infections among children and is a complication in about 30% of common colds. The most common complication of acute otitis media is otitis media with effusion. Some studies have reported the effects of montelukast and mometasone nasal spray in treatment of otitis media with effusion. However, current information is inadequate in this issue. The aim of this study was to compare the effectiveness of montelukast and mometasone nasal spray in treatment of otitis media with effusion in children attending Koodakan hospital in Bandar Abbas, Iran.

Enrollment: 143 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Children who were between 2 to 6 years old

  • Definite diagnosis of OME with symptoms and examination

Exclusion criteria

• • Currently were using corticosteroids or prophylactic monteleukast

  • Chronic pulmonary or cardiac diseases or immune deficiency
  • Allergic rhinitis
  • Hypersensitivity to monteleukast or corticosteroids
  • Avoidance of parents to fill the written informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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143 participants in 3 patient groups

Montelukast

Experimental group

Description:

4 ml monteleukast daily for one month

Treatment:

Drug: Monteleukast

Mometasone

Active Comparator group

Description:

Inhaled mometasone 1 puff in each side of nose for one month

Treatment:

Drug: Mometasone

Control

No Intervention group

Description:

No intervention